Question of the Day

Have you been impacted by the government shutdown?

In his weekly radio address, President Clinton called for Congress to give the Food and Drug Administration (FDA) what the agency thought it had up until last week: the power to regulate tobacco. The Supreme Court has just taken it away, and FDA can't blame anything but the statutes that govern the agency. In a 5-4 decision, the justices held that if FDA actually had authority to regulate tobacco products, it would have no choice but to ban them. Since the record shows Congress doesn't want tobacco banned, it obviously never gave FDA the authority to do so.

Ostensibly this case was about keeping cigarette makers from corrupting the youth of America through the use of eye-catching ads Joe Camel among them and other tactics intended to tempt them into bad habits. In 1996, President Clinton reversed decades of FDA policy by announcing that the agency had jurisdiction over tobacco products after all. Previously the agency had argued tobacco regulation was Congress' job, and lawmakers had never done anything to disabuse them of the notion. Indeed, it repeatedly turned down proposals to give FDA the job.

The administration explained its flip-flop by saying that 1) cigarettes are a combination of drug (nicotine) and device (cigarette) and 2) that FDA has the statutory authority to regulate drug delivery devices. On that basis and in the name of children, the agency announced new restrictions on how and when the industry could advertise its products. It forbade, for example, ads near schools and playgrounds, and it banned promotional giveaways. The agency also ordered stores to check identification of anyone 27 years old and younger. Concerns about establishing a federal tobacco patrol and about diminishing free, if unpopular, speech were lost in the huzzahs that followed the proposal.

But when the plan ended up in court after manufacturers sued, the argument turned away from the administration's wonderful intentions toward questions about whether it had the authority to carry them out. On that basis, a federal district court in North Carolina threw out some of the regulations in 1997, and the 4th U.S. Circuit Court of Appeals threw out the remainder in 1998.

Alas for the agency, its arguments didn't fare any better at the Supreme Court. Writing for the court majority, Justice Sandra Day O'Connor noted that by law, the agency must prohibit the introduction of drugs and devices that are "misbranded." Again by law, any drug or device is considered misbranded if it is dangerous when used in the amount recommended or suggested on the label. In view of the fact that the agency has referred to smoking as a "pediatric disease," that it blames as many as 400,000 premature deaths annually on smoking, to say nothing of all sorts of other health problems, FDA believes smoking is "dangerous to health" no matter how much or how little. Hence were tobacco products within the FDA's jurisdiction, Justice O'Connor wrote, the Act would deem them misbranded devices that could not be introduced into interstate commerce. Indeed, former FDA Commissioner Charles Edwards said at congressional hearings in 1972 that if FDA regulated tobacco products as "drugs" the basis for the Clinton administration's 1996 proposal "they would have to be removed from the market because it would be impossible to prove they were safe for their intended use."

But the record shows Congress has never wanted tobacco banned. Says the U.S. Code, the "marketing of tobacco constitutes one of the greatest basic industries of the United States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary to the general welfare." That didn't sound like grounds for prohibition to the majority, and, based in part on this "inconsistency," the five ruled the agency had no authority to regulate tobacco as a drug or device.

The point is that until the people's elected representatives have signed off on FDA's good intentions, they aren't lawful. And to the extent they deprive people of their voice in this democracy, they hardly qualify as good, either.